5 - 8 years
5 - 10 Lacs
Posted:1 month ago|
Platform:
Work from Office
Full Time
Role & responsibilities Hands on experience required on handling of Process validation and Cleaning validation Design and execute validation protocols for process and cleaning validation activities, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and CV (Cleaning Validation). Develop and maintain a validation master plan (VMP) that aligns with regulatory requirements and organizational goals. Conduct process validation studies to ensure manufacturing processes consistently produce products that meet predefined quality attributes. Analyze process performance and critical parameters during validation runs and document results. Ensure adherence to Good Manufacturing Practices (GMP) during all validation activities. Develop and execute cleaning validation protocols to confirm the effectiveness of cleaning procedures in removing residues, contaminants, and microorganisms. Establish acceptable residue limits and cleaning verification procedures based on product toxicology and batch size. Monitor cleaning practices and perform periodic revalidation as required.
Alembic Pharmaceuticals
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